Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy

Colorectal Cancer Clinical Trial

Official title:

Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749589
• Other study ID #: 21 6250
• Status: Completed
• Start date: February 11, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: August 2023
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim is to investigate if iron deficiency at the time of colorectal cancer diagnosis has an influence on fatigue, quality of life, cognition and physical ability.

Description:

Around 60% of newly diagnosed colorectal cancer patients suffer from iron deficiency at the time of diagnosis. The study hypothesis is that, besides leading to anemia, iron deficiency might be associated with impaired patient report outcomes in the domains of fatigue, quality of life, cognitive impairment and lower physical ability. No previous studies on colorectal cancer patients and iron deficiency are available.

The participants (patients suspected of colorectal cancer after endoscopy) will be tested on these parameters. The participants and the investigators are blinded to the patients iron status. The study takes place before any preoperative iron treatment. Multivariate analysis will be used taking into account, gender, age, hemoglobin, tumor stage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients in whom endoscopy has raised suspicion of colorectal malignancy

Exclusion Criteria:

• non fluent in Danish language

• cerebral impairment (ex severe dementia) so that informed consent can not be obtained

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Cognitive Impairment
• Colorectal Cancer
• Fatigue
• Iron Deficiency Anemia
• Iron-deficiency
• Quality of Life

Intervention

Diagnostic Test:
• iron deficiency
Its not an intervention. Its an observational study. The groups are defined based on their iron status

Locations

Country	Name	City	State
Denmark	Sygehus Sønderjylland	Aabenraa	Region Of Southern Denmark
Denmark	Hospital of South West Jutland	Esbjerg	Region Of Southern Denmark
Denmark	Hospital of South West Jutland	Grindsted	Region Of Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Hospital of South West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	post-operative run	the ability of the above mentioned test to predict the postoperative run (complications/length of stay)	30-days postoperatively
Primary	Fatigue	Fatigue sub-scale of Focussed assessment of cancer treatment - anemia	up to one months after inclusion
Secondary	Quality of life	European Organisation for Research and Treatment of Cancer C30	up to one months after inclusion
Secondary	Cognitive ability	Montreal cognitive assessment	up to one months after inclusion
Secondary	endurance	6 minutes walk test	up to one months after inclusion
Secondary	peripheral muscular strengths	hand-held dynamometer	up to one months after inclusion
Secondary	mobility and balance	timed-up-and-go-test	up to one months after inclusion